Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Palabras clave
Abstracto
Descripción
PRIMARY OBJECTIVES:
I. To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with sentinel lymph node (SLN) biopsy compared to elective neck dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0). (Phase II) II. To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III) III. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III)
SECONDARY OBJECTIVES:
I. To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.
II. To measure and compare overall survival (OS) between surgical arms. III. To measure and compare the toxicity of the two surgical arms.
IV. To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments:
IVa. Neck Dissection Impairment Index (NDII). IVb. Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH). IVc. Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N). V. To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.
VI. To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.
VII. To assess nodal metastases rates between arms. VIII. To assess the pathologic false omission rate (FOR) in the SLN biopsy arm. IX. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients.
EXPLORATORY OBJECTIVES:
I. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between surgical arms.
II. To collect biospecimens for future translational science studies. III. To assess the DFS between arms in low-risk patients.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive an imaging agent via injection and undergo planar imaging and single photo emission computed tomography/computed tomography (SPECT/CT) over 1-2 hours. Patients then undergo SLN biopsy.
GROUP II: Patients undergo standard END.
After completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.
fechas
| Verificado por última vez: | 06/30/2020 |
| Primero enviado: | 03/25/2020 |
| Inscripción estimada enviada: | 04/01/2020 |
| Publicado por primera vez: | 04/02/2020 |
| Última actualización enviada: | 07/05/2020 |
| Última actualización publicada: | 07/07/2020 |
| Fecha de inicio real del estudio: | 06/30/2020 |
| Fecha estimada de finalización primaria: | 05/17/2031 |
| Fecha estimada de finalización del estudio: | 05/17/2036 |
Condición o enfermedad
Intervención / tratamiento
Procedure: Computed Tomography (CT)
Drug: Sentinel Lymph Node (SLN) Biopsy
Procedure: Elective Neck Dissection (END)
Procedure: Sentinel Lymph Node (SLN) Biopsy
Procedure: Sentinel Lymph Node (SLN) Biopsy
Procedure: Sentinel Lymph Node (SLN) Biopsy
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Sentinel Lymph Node (SLN) Biopsy Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy. | Drug: Sentinel Lymph Node (SLN) Biopsy Receive imaging agent via injection |
| Active Comparator: Elective Neck Dissection (END) Patients undergo standard END. | Procedure: Elective Neck Dissection (END) Undergo standard elective neck dissection |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - PRIOR TO STEP 1 REGISTRATION INCLUSION: - Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration - Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer [AJCC] 8th edition [ed.]) based on the following diagnostic workup: - History/physical examination within 42 days prior to registration - Imaging of head and neck within 42 days prior to registration - PET/CT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic resonance imaging (MRI) or lateral and central neck ultrasound; CT portion of the PET/CT must be of diagnostic quality - Chest imaging with either a chest x-ray, CT chest scan (with or without contrast) or PET/CT (with or without contrast) within 42 days prior to registration - Surgical assessment within 42 days prior to registration. Patient must be a candidate for surgical intervention with sentinel lymph node (SLN) biopsy and potential completion neck dissection (CND) or elective neck dissection (END) - Surgical resection of the primary tumor will occur through a transoral approach with anticipation of resection free margins - Zubrod performance status 0-2 within 42 days prior to registration - For women of child-bearing potential, negative serum or urine pregnancy test within 42 days prior to registration - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry - Only English-speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language - PRIOR TO STEP 2 RANDOMIZATION: - FDG PET/CT required prior to step 2. Note: FDG PET/CT done prior to step 1 can be submitted for central review. However, if the FDG PET/CT is not of diagnostic quality, then FDG PET/CT will have to be repeated prior to Step 2 registration - PET/CT node negative patients, determined by central read, will proceed to randomization. - PET/CT positive patients will go off study, but will be entered in a registry and data will be collected to record the pathological outcome of neck nodes for diagnostic imaging assessment and future clinical trial development - NOTE: All FDG PET/CT scans must be performed on an American College of Radiology (ACR) accredited scanner (or similar accrediting organization) Exclusion Criteria: - PRIOR TO STEP 1 REGISTRATION EXCLUSION: - Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease - Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years - Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx - Unable or unwilling to complete NDII (baseline only) - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection - Pregnancy and breast-feeding mothers - Incomplete resection of oral cavity lesion with a positive margin; however, an excisional biopsy is permitted - Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious nodes that are ≥ 1 cm with radiographic finding suggestive of NOT malignant should be biopsied using ultrasound-guided (U/S-guided) fine-needle aspiration (FNA) biopsy - Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia [CLL]) or other active disease capable of causing lymphadenopathy (sarcoidosis or untreated mycobacterial infection) - Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy - Currently participating in another investigational therapeutic trial |
Salir
Medidas de resultado primarias
1. Patient-reported neck and shoulder function (Phase II/III) [From Baseline (Before surgery) to 6 months post-surgery]
2. Disease-Free Survival [From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years]
Medidas de resultado secundarias
1. Overall Survival [From randomization to death due to any cause, assessed up to 11 years]
2. Loco-regional Failure [From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 11 years]
3. Distant metastasis [From the time of randomization to the date of distant metastasis, date of precluding event, or last known follow-up date, assessed up to 11 years]
4. Patient-reported shoulder-related QOL, function impairment and disability [Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.]
5. General quality of life [Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.]
6. Nodal metastasis detection rate [During surgery. Analysis occurs at the same time as the primary endpoint.]
7. Pathologic false omission rate [During surgery. Analysis occurs at the same time as the primary endpoint.]
8. Post-surgery patient-reported outcome [At 6 months post-surgery. Analysis occurs at the same time as the primary endpoint.]
